Vascular closure system with introducer for sheath transfer

ABSTRACT

A system includes an introducer configured to be inserted through the puncture along a guidewire that extends through the puncture into the vessel. The introducer includes an introducer body, a proximal tapered tip, a distal tapered tip that is opposite to the proximal tapered tip along the central axis, and a bore that extends from the proximal tapered tip to the distal tapered tip along the central axis. The system includes an access sheath configured to be inserted over the introducer. The access sheath includes a front end, a rear end opposite to the front end, and a lumen that extends from the front end to the rear end. The proximal tapered tip of the introducer is configured to be inserted into the front end and through the lumen of access sheath, such that a movable interference fit is attained between the access sheath and the introducer.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit and priority to U.S.Provisional Application Ser. No. 62/278,298, filed Jan. 13, 2016, theentire disclosure of which is incorporated by reference into the presentapplication for all purposes.

TECHNICAL FIELD

The present disclosure relates to vascular closure system with anintroducer configured for sheath transfer.

BACKGROUND

During an interventional cardiovascular procedure a puncture may be madein the femoral artery. Advanced cardiovascular procedures may obtainaccess to the aorta via the vena cava in situations where the femoralartery is not a suitable approach path. In one example, the procedure isa trans-caval aortic valve replacement procedure, or “trans-caval”procedure. Vascular closure devices composed of an absorbableintra-arterial toggle, an extra-vascular folding sealing plug, and aconnecting suture, such as a filament, have been developed and may beused to seal these punctures. These devices function by compressing theintra and extra-arterial components together around the puncture, withsufficient tension within the connecting suture. However, as the size ofpercutaneous sheaths become larger to accommodate larger cardiovasculardevices, the size of the resulting puncture increases. Larger puncturesare harder to seal because of the larger vessel wall defect or puncture.In the case of sealing blood pressure with an external plug, largerdefects expose the plug to increased forces, which must be supportedthrough the connecting suture by the intra-arterial toggle.

SUMMARY

An embodiment of the present disclosure is a system configured to seal apuncture in the vessel. The system includes an introducer configured tobe inserted through the puncture along a guidewire that extends throughthe puncture into the vessel. The introducer includes an introducer bodythat is elongate along a central axis, a proximal tapered tip, a distaltapered tip that is opposite to the proximal tapered tip along thecentral axis, and a bore that extends from the proximal tapered tip tothe distal tapered tip along the central axis. The bore is sized toreceive the guidewire therethrough, wherein the distal tapered tip isconfigured to be inserted into the vessel along the guidewire. Thesystem includes an access sheath configured to be inserted over theintroducer and into the vessel. The access sheath includes a front end,a rear end opposite to the front end, and a lumen that extends from thefront end to the rear end. The proximal tapered tip of the introducer isconfigured to be inserted into the front end and through the lumen ofthe access sheath, such that a movable interference fit is attainedbetween the access sheath and the introducer. The system furtherincludes a vascular closure device including a sealing elementconfigured to seal the puncture of the vessel. When the introducer hasbeen removed from the lumen of the access sheath, the rear end of theaccess sheath is configured to receive the vascular closure device suchthat the sealing element extends out of the front end of the accesssheath. Related methods are disclosed.

The use of the introducer limits blood loss during an exchange of aprocedure access sheath used to guide a catheter (or other medicaldevice) into the vessel, e.g. the femoral artery or the aorta, with anaccess sheath for use with a vascular closure device.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofan exemplary embodiments of the application, is better understood whenread in conjunction with the appended figures. The figures illustrateexemplary embodiments for the purposes of illustration. It should beunderstood, however, that the application is not limited to the precisearrangements and systems shown.

FIG. 1 is a perspective view of a vascular closure system in accordancewith an embodiment of the present disclosure;

FIG. 2A is a perspective view of an introducer and an access sheath ofthe system shown in FIG. 1;

FIG. 2B is a perspective view of the vascular closure device and accesssheath of the system shown in FIG. 1;

FIG. 3 is a side view of the introducer shown in FIG. 1;

FIG. 4A is a side view an introducers according to an embodiment of thepresent disclosure;

FIG. 4B is a side view an introducers according to another embodiment ofthe present disclosure;

FIG. 4C is a side view an introducers according to another embodiment ofthe present disclosure;

FIG. 5A is a perspective view of a vascular closure device in accordancewith an embodiment of the present disclosure;

FIG. 5B is a partial cut-away view of the vascular closure device shownin FIG. 5A;

FIG. 5C is a perspective view of a sealing device associated with thevascular closure device in FIG. 5A;

FIG. 5D is a side sectional view of a distal portion of the vascularclosure device;

FIGS. 6A-6C are rear perspective views of the vascular closure devicewith portions of the device removed for clarity;

FIG. 6D is a sectional view of the vascular closure device shown in FIG.6A;

FIG. 6E is a perspective view of the release component, deliverycomponent, and tensioner of the vascular closure device shown in FIG.6A;

FIG. 6F is a perspective cross-sectional view of the a releasecomponent, delivery component, and a tensioner of the vascular closuredevice shown in FIG. 6E, taken along line 6F-6F;

FIG. 6G is a perspective view of the delivery component and tensioner ofthe vascular closure device shown in FIG. 6E;

FIGS. 6H and 6I are perspective and top views, respectively, of therelease component of the vascular closure device shown in FIG. 5A;

FIG. 7A is a schematic showing an access sheath from a cardiovascularsurgical procedure partially disposed within a vessel through puncturesites in a vessel;

FIG. 7B is a schematic showing the introducer from FIG. 1 inserted inthe access sheath shown in FIG. 7A;

FIG. 7C is a schematic showing the removal of the access sheath from thevessel with the introducer remaining in position;

FIG. 7D is a schematic showing the access sheath of the system shown inFIG. 1 inserted into the vessel along the introducer sheath;

FIG. 7E is a schematic showing the introducer removed from the accesssheath and the vascular closure device positioned for insertion into theaccess sheath;

FIG. 7F is a schematic showing the sealing element fully sealing thepuncture site.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Certain terminology is used in the following description for convenienceonly and is not limiting. The words “right”, “left”, “lower” and “upper”designate directions in the drawings to which reference is made. Thewords “proximally” and “distally” refer to directions toward and awayfrom, respectively, the individual operating the system. The terminologyincludes the above-listed words, derivatives thereof and words ofsimilar import.

Referring to FIGS. 1-2B, the vascular closure system 10 includes anintroducer 100 and a closure device 12 that is configured to seal thepuncture in a vessel wall. The introducer 100 is configured tofacilitate placement of the closure device 12 into the desired positionwithin a puncture site of a vessel wall following a surgical procedure.The closure device 12 includes a deployment assembly 14 and an accesssheath 23. The access sheath 23 can be inserted into the vessel and thedeployment assembly 23 can be inserted into the access sheath 23 toposition a sealing device or implantable unit 18 (FIG. 5C) into thevessel. The access sheath 23 and introducer 100 can be referred to asinsertion assembly 15.

FIGS. 3-4B illustrates the embodiments of an introducer 100. Theintroducer 100 is configured to be inserted through the puncture along aguidewire 35 (FIG. 7A) that extends through the puncture into thevessel. The introducer 100 includes an introducer body 102 that iselongate along a central axis 9, a proximal tapered tip 106 a distaltapered tip 104 that is opposite to the proximal tapered tip 106 alongthe central axis 9, and a bore 108 that extends from the proximaltapered tip 106 to the distal tapered tip 104 along the central axis 9.The bore is sized to receive the guidewire 35 (not shown) therethrough.The distal tapered tip of the introducer is configured to be insertedinto the vessel along the guidewire 35.

In one embodiment as shown in FIGS. 4A and 4B, the introducer 100includes a proximal component 120 that defines the proximal tapered tip106, and a distal component 110 that defines the distal tapered tip 104.The proximal component 120 and the distal component 110 are configuredto be coupled together to define the introducer body 102 of theintroducer. The proximal component defines a proximal portion of thebore 108. The distal component defines a distal portion of the bore 108that is aligned with the proximal portion of the bore when the proximaland distal components are coupled together.

The introducer body 102 defines an outer surface 122 and outercross-sectional dimension C that is perpendicular to the central axis 9.As illustrated, the outer cross-sectional dimension C does not varyalong an entirety of the introducer body 102 between the proximaltapered tip 106 and the distal tapered tip 104. The proximal tapered tip106 tapers from the outer surface 122 toward the central axis 9 along aproximal direction 4 away from the distal tapered tip 104. Furthermore,the distal tapered tip 104 tapers from the outer surface 122 toward thecentral axis 9 along a distal direction 2 that is opposite to theproximal direction 4. The introducer 100 (or introducer body 102) isconfigured to be inserted through the front end 21 f and into the lumenof access sheath 23 such that a movable interference fit is attainedbetween the access sheath 23 and the introducer 100. A moveableinterference fit is where the introducer can be inserted into the accesssheath 23 so as to permit the introducer 100 to move through the accesssheath but does it not prevent its effective use. A user can thereforeexert some level of force to advance the introducer along the guidewireinto and partially through the access sheath 23 while still prevent freepassage of blood or other fluids between the introducer 100 and theaccess sheath 23. Likewise, the access sheath 23 can be removed from theintroducer 100 as needed. Thus, an interference fit interferes with freepassage of blood or other fuilds between the access sheath andintroducer. However, a person of ordinary skill would understand thatthere may be some small amount of fluid loss even with such aninterference fit.

As shown in FIGS. 2A and 3, the introducer body 102 further defines anintroducer length L1 that extends from the proximal tapered tip 160 tothe distal tapered tip 104 along the central axis 9. The access sheath23 defines a sheath length L2 that extends from the front end 21 f tothe rear end 21 r. The length L1 of the introducer 100 is at least twotimes longer than the length L2 of the sheath 23. In one embodiment ofthe present disclosure, such when the system is used to seal puncturedeep in thoracic cavity following a trans-caval procedure, theintroducer length L1 is between about 120 cm and about 130 cm. In oneexample of such an embodiment, the introducer length is between about123 cm and about 127 cm. In another example, the introducer length isabout 125 cm. In another embodiment, such as when the system is used toseal puncture in vessel within patient's limb, the introducer length L1can be between about 20 cm and about 30 cm. In one example of such anembodiment, the introducer length is between about 23 cm and about 27cm. In another such example, the introducer length is about 25 cm.

As shown in FIG. 3, the introducer body 102 includes at least one marker130. Thus, there may be a single marker 130 or a plurality of markers.In an event, the marker 130 can be positioned to aid in identifying thelocation of the introducer 100 in the vessel. The marker 130 is one of aradio opaque band, a radio opaque ink, or a radio opaque paint. Inaccordance with one embodiment, a distance D1 from the distal taperedtip 104 to the marker 130 is less than a distance D2 from the marker 130to the proximal tapered tip 106.

Referring to FIGS. 3-4C, the proximal component 120 and the distalcomponent 110 are configured to be coupled together. In accordance withthe illustrated embodiment, the proximal component 120 defines a firstengagement member 140 opposite to the proximal tapered tip 106, and thedistal component 110 defines a second engagement member 150 opposite tothe distal tapered tip. The first engagement member 140 is configured toengage the second engagement member 150 so as to couple the proximal anddistal components together.

The proximal component 120 and the distal component 110 are configuredto be coupled together via one an interference fit. Accordingly, asillustrated in FIG. 4A, the first engagement member 140 defines aprojection 142, and the second engagement member 150 defines a cavity152 sized to receive the projection 142. However, it should beappreciated that one of the first engagement member 140 and the secondengagement member 150 defines a cavity, and the other of the firstengagement member 140 and the second engagement member 150 defines aprojection that is sized to fit in the cavity. Accordingly, eithercomponent 110, 120 may have the projection or cavity as needed.

FIG. 4B illustrates another embodiment an introducer 300 that couplesthe proximal component and the distal component via a snap-fitconnection. The introduce 300 is substantially similar to the introducer100 described above and shown in FIG. 4A. For this reason, similarreference numbers are used to identify features that are common tointroducer 100 and introducer 300. The introducer 300 includes aproximal component 120 and a distal component 110. In accordance withthe embodiment shown in FIG. 4B, a first engagement member 340 includesa ridge 342 and the second engagement member 350 includes a groove 352that is sized to receive the ridge 342. However, it should beappreciated that one of the first engagement member 340 and the secondengagement member 350 defines a ridge, and the other of the firstengagement member 340 and the second engagement member 350 defines agroove that is sized to receive the ridge.

In another alternative embodiment, the proximal component and the distalcomponent an introducer may be configured to be coupled together via athreaded connection (not shown). For instance, one of the firstengagement member and the second engagement member define externalthreads, and the other of the first engagement member and the secondengagement member define internal threads configured to threadably matewith the external threads.

FIG. 4C illustrates another embodiment an introducer 400 that couplesthe proximal component and the distal component via a coupler 480. Theintroducer 400 is substantially similar to the introducer 100 describedabove and shown in FIG. 4A. For this reason, similar reference numbersare used to identify features that are common to introducer 100 andintroducer 400. As shown in FIG. 4C, the introducer 400 includes acoupler 480 having a first end 482 and a second end 484 opposite thefirst end 482. The first end 482 is configured to be coupled to theproximal component 120 and the second end 484 is configured to becoupled to the distal component 110. The first and second ends 482 and484 have first and coupling members 486 and 488, respectively. The firstcoupling member 486 can connect to the first engagement member 440 ofthe proximal component 120. The second coupling member 488 can connectto the second engagement member 450 of the distal component 110. Theproximal component 120, the coupler 480, and the distal component 110when coupled together can define the introducer 400. The engagementmembers 440, 450 and the coupling members 486,488 can be ridges,projections, tabs, or other structures or devices that can coupled partsto each other. Accordingly, the coupler 380 and ends of the distalcomponent 110 and proximal component 120 may be configured for any typeof connection, such as an interference fit, snap-fit, threadedconnection, or the like.

Referring generally to FIGS. 3-4C, the proximal tapered tip 106 of theintroducer 100 is configured to be inserted into the front end 21 f andof the access sheath 23 and through the lumen of access sheath 23. Thesealing element 18 extends out from the front end 21 f of the accesssheath when the portion of the vascular device is coupled to the hub 21b.

As shown in FIGS. 1 and 2A, the access sheath 23 is configured to beinserted over the introducer 100 and into the vessel. The access sheath23 includes a hub 21 b and shaft 21 d that extends from the hub 21 b inthe distal direction 2. The access sheath 23 has a front end 21 f, arear end 21 r opposite to the front end 21 f, and a lumen (not numbered)that extends from the front end 21 f to the rear end 21 r. The rear end21 r of the access sheath includes the hub 21 b that is configured to becoupled to a portion of the deployment assembly 14. When sheath 23 iscoupled to the deployment assembly 14, the shaft 21 d extends along therelease component 22 and delivery component 26 in the distal direction2.

Referring to FIG. 5A-5D, a vascular closure device 12 includes a sealingdevice or implantable unit 18 at least partially disposed within adeployment assembly 14. The vascular closure device 12 can be configuredsuch that after a distal portion of deployment assembly 14 is insertedthrough a puncture site of the vessel, the sealing device 18 is deployedto thereby seal or otherwise close the puncture site of the vessel. Thedeployment assembly 14 is configured to control orientation of a toggle40 of the sealing device 18 in an easier and more efficient mannerduring deployment of the sealing device 18. Furthermore, the deploymentassembly 14 is configured to reduce forces required to deploy thesealing device 18 and seal the puncture.

In accordance with the illustrated embodiment, the deployment assembly14 includes a release component 22 that restrains the toggle 40, adelivery component 26 that contains at least a portion of the toggle 40and a suture 44 of the sealing device 18, a guide member 35, and one ormore actuators 38 coupled to the release component 22. The deploymentassembly 14 may also include a tamper 70, in the form a tube, thatextend along the suture 44 is a located proximal with respect to thelocking member 230 (See FIG. 5D). The guide member 35 extends throughthe sealing device 18 and is configured to receive a guidewire 35 aswill be discussed below. In another example, the deployment assembly 14can be configured so that the guidewire 35 extends along the side of thetoggle 40. The release component 22 is operatively associated with thesuture 44 such that actuation of the actuator 38 causes the releasecomponent 22 to 1) release the toggle 40, and 2) apply tension to thesuture 44, which urges the toggle 40 against the delivery component 26and orients the toggle 40 in the sealing position. The guide member 35is configured to be removed from at least the sealing device 18 priorthe sealing device 18 sealing the puncture.

Turning to FIG. 5C, the sealing device 18 includes the toggle 40connected to the suture 44, a plug 88 coupled to the suture 44 andspaced from the toggle 40 in a proximal direction 4, and a lockingmember 230 proximal to the plug 88. The toggle 40 includes a distal end45 d and a proximal end 41 p opposite to the proximal end 41 p, and aplurality of apertures (not numbered) extending therethrough. The suture44 extends through the apertures as illustrated such that an end of thesuture 44 is formed into a slidable knot 232. The knot 232 is slidablealong the suture 44 between the plug 88 and the locking member 230. Inan implanted state, the toggle 40 is adjacent an inner surface of thevessel and the locking member 230 squeezes the toggle 40 the plug 88against the vessel to seal the puncture. See for example FIG. 7F.

The sealing device 18 is formed with materials suitable for surgicalprocedures such as any biocompatible material. For example, the toggle40 can be made of a polylactic-coglycolic acid or other syntheticabsorbable polymer that degrades in the presence of water into naturallyoccurring metabolites. In other embodiments, the toggle can be made ofstainless steel, biocorrodible iron, and biocorrodible magnesium. Itshould be appreciated, however, that the toggle 40 can be made of othermaterials and can have other configurations so long as it can be seatedinside the vessel against the vessel wall. The plug 88 can comprise astrip of compressible, resorbable, collagen foam and can be made of afibrous collagen mix of insoluble and soluble collagen that is crosslinked for strength. It should be appreciated, however, that the plugmember 88 can have any configuration as desired and can be made from anymaterial as desired. The suture 44 can be any elongate member, such as,for example a filament, thread, or braid.

Referring again FIGS. 5A, 5B and 5D, the deployment assembly 14 iselongate along a longitudinal direction L and includes a rear end 16 pand a front end 16 d spaced from the rear end 16 p along an axis 6 thatis aligned with the longitudinal direction L. The longitudinal directionL can include and define a distal direction 2 that extends from the rearend 16 p toward the front end 16 d. Further, the longitudinal directionL can include and define a proximal direction 4 that is opposite thedistal direction 2 and that extends from front end 16 d toward the rearend 16 p. The deployment assembly 14 is configured to insert the toggle40 into the vessel along an insertion direction I (see FIG. 4). Thelongitudinal direction L can be aligned with the insertion direction Iduring a portion of the sealing procedure.

Turning to FIGS. 5A and 5B, in accordance with the illustratedembodiment, the deployment assembly 14 includes a handle member 20, therelease component 22 supported by the handle manner 20 and extendingfrom handle member 20 in the distal direction 2, the delivery component26 also supported by the handle member 20 and extending along the distaldirection 2, and a tensioner 28 supported by the handle member 20 andpositioned adjacent to the release component 22. A portion of deliverycomponent 26 is shown in dashed lines in FIGS. 5A and 5B.

The actuator 38 is coupled to both the handle member 20 and the releasecomponent 22. As noted above the actuator 38 is configured to 1) causethe release component 22 to move in the proximal direction 4 from afirst or initial position relative to the delivery component 26 into asecond or releasing position relative to the delivery component 26, and2) apply a tensile force to the suture 44 during or subsequent tomovement of the release component 22 from the initial position into thereleased position. The description below refers to the release component22 being moveable relative to the delivery component 26. But thedeployment assembly 14 can be configured so that the delivery component26 is moveable relative to the release component 22. The deploymentassembly 14 also includes the guide member 35 that extends through thedeployment assembly 14, and an outer sheath 23 that contains andsupports portions of the release component 22 and delivery component 26.Furthermore, the actuator 38 may be adapted to operate, or cause movethe tamper 70 along the suture 44 to tamp the sealing unit into atamped, deployed configuration. In alternative embodiment, an separateactuator may be used to control the tamper 70.

Continuing with FIGS. 5A and 5B, the handle member 20 includes a housing21 a and a cavity 21 c defined at least partly by housing 21 a and anose 21 b of the access sheath 23. The cavity 21 c is sized to contain aportion of the release component 22, delivery component 26, and thetensioner 28.

Turning to FIGS. 5B, 6H and 6I, the release component 22 is elongatealong a first or longitudinal direction L defines a distal end 25 d anda proximal end 25 p spaced from the distal end 25 d along thelongitudinal direction L. In accordance with the illustrated embodiment,the release component 22 includes a release hub 24 and a release tube 46that is fixed to the release hub 24 extends from the release hub 24 inthe distal direction 2. The release hub 24 includes a pair of tabs 29 a,29 b disposed at the proximal end 25 p of the release component 22. Apulley 60 is coupled to the tabs 29 a, 29 b and defines a curved trackthat receives the suture 44 as will be explained below. The hub 24defines a slot 47 that is elongate along the longitudinal direction Land is aligned with the release tube 46. The slot 47 is sized toreceiver a coupler 30 of the tensioner 28.

The release tube 46 includes a release tube body 48 that is elongatealong the longitudinal direction L. The release tube body 48 defines arelease tube channel 52 that extends along the longitudinal direction Lfrom the hub 24 toward the proximal end 25 p. In the illustratedembodiment, the release tube channel 52 (FIG. 6D) extends completelythrough the release tube body 48 from the hub 24 to the distal end 25 d.Furthermore, in the illustrated embodiment the release tube body 48 iscylindrical such that the release tube channel 52 is radially enclosed.It should be appreciated, however, that the release tube channel 52 canextend partially through the release tube body 48 as desired and thatthe release tube body 48 can have other configurations as desired. Forexample, the release tube body 48 can be U-shaped such that the releasetube channel 52 is partially radially open. As shown, the release tubechannel 52 is sized to slidably receive a portion of the deliverycomponent 26 such that the release component 22 is movable relative tothe delivery component 26.

Referring to FIGS. 6A, 6B, 6D, and 6I, the pulley 60 is disposed at theproximal end 25 p of the release component 22. As shown, the suture 44extends around the pulley 60 along the guide track and into thetensioner 28. As the release component 22 is pulled in the proximaldirection 4, the pulley 60 pulls the suture 44 in proximal direction 4thereby applying a tensile force to the toggle 40. In such anembodiment, the tensioner 28 is positioned alongside the releasecomponent 22. It should be appreciated, however, that in someembodiments, the tensioner 28 is positioned proximal to the release tubeand is in-line with the release component 22 such that the suture 44extends through the release tube and into the tensioner 28 along thefirst direction L.

With continued reference to 6A, 6B, 6D, and 6I, the release component 22can include at least one mating member 64 that mates with acorresponding mating member 68 of the actuator 38 to thereby transferthe motion of the actuator 38 to the release component 22. In theillustrated embodiment, the release component mating member 64 is a pairof slots 65 a and 65 b defined by the respective pair of tabs 29 a and29 b. Each slot 65 a and 65 b is elongate along a direction a verticaldirection V that is perpendicular to the first direction L. The actuator38 mating member 68 can be operatively engaged with elongate slots 65 aand 65 b of release component 22 such that actuation of the actuator 38causes the release component 22 to translate along the first directionL. It should be appreciated, however, that the mating member 64 can haveany configuration as desired. For example, the mating member 64 can be abore having a diameter that is equal to that of the pin such thattranslation of the actuator 38 along the first direction L causes therelease component 22 to translate along the first direction L.

As shown in FIGS. 5B, 6D-6G, the delivery component 26 is coupled to thetensioner 28 and extends along the release component 22 toward the frontend 16 d of the deployment assembly 14. In accordance with theillustrated embodiment, because the tensioner 28 is fixed to the housing21 a, the delivery component 26 is fixed to the housing 21 a and thusthe handle member 20. The delivery component 26 includes a delivery tubebody 80 that is elongate along the first direction L and defines adistal end 27 d and a proximal end 27 p spaced from the distal end 27 din the first direction L. The delivery tube body 80 defines an innersurface 81, which in turns defines a delivery tube channel 84 thatextends at least partially through the delivery tube body 80 along thefirst direction L. As illustrated embodiment, the delivery tube channel84 extends completely through the delivery tube body 80 from theproximal end 27 p to the distal end 27 d. However, the channel 84 canextend along a portion of the delivery tube body 80. Furthermore, in theillustrated embodiment the delivery tube body 80 is cylindrical suchthat the delivery tube channel 84 is radially enclosed. It should beappreciated, however, that the delivery tube channel 84 can extendpartially through the delivery tube body 80 as desired and that thedelivery tube body 80 can have other configurations as desired. Forexample, the delivery tube body 80 can be U-shaped such that thedelivery tube channel 84 is partially radially open. As illustrated, theproximal end 27 p of delivery component is fixed to the tensioner 28 andthe distal end 27 d of delivery component is configured to hold at leasta portion of the sealing device 18 (FIG. 5D).

The delivery tube channel 84 is sized to retain at least a portion ofthe sealing device 18. In particular, the plug 88 and locking member 230are retained within the delivery tube channel 84, while the toggle 40 isconfigured to be initially trapped between the delivery component 26 andthe release component 22. For instance, the distal end 25 d of therelease tube 48 defines an offset surface 49, which can be angled withrespect to the longitudinal axis 6. The offset surface 49 and innersurface 81 of the delivery tube 80 define a cavity 51 that receives theproximal end 41 p of the toggle 40 when release component 22 is in theinitial position (as shown in FIG. 5D). The angle of the offset surface49 can define the orientation of the toggle 40 in this initial position,whereby the distal end 45D of the toggle 40 is spaced some distance inthe distal direction 2 beyond the distal ends 25 d and 27 d of therelease component 22 and delivery component 26, respectively. The suture44 extends from the toggle 40 through the delivery tube channel 84,through the proximal end 27 p (FIG. 6D) around the pulley 60 along theguide track and is coupled to the tensioner 28. The guide member 35extends through the channel 84 and exits the front end 16 d of thevascular closure device 12. When the actuator 38 is actuated as will befurther detailed below, the release component 22 moves in the proximaldirection 4 thereby releasing the proximal end 41 p of the toggle 40from between the release component 22 and the delivery component 26. Asthe release component 22 moves in the proximal direction 4, the suture44 will be pulled in the proximal direction 4 to thereby place thesuture 44 in tension and urge the toggle 40 against the distal end 27 dof the delivery component 26. At this point, the toggle 40 is orientedin the sealing position (see FIG. 6E). In the sealing position, thetoggle 40 has been repositioned so that the toggle 40 is placed againstthe distal end 27 d of the delivery component 26 and is oriented moretransversely with respect to the axis 6 compared to the position whenthe toggle 40 is restrained by the release component 22.

As shown in FIGS. 6D-6G, the tensioner 28 disposed on the deliverycomponent 26 and is positioned alongside the release component 22 so asto receive the suture 44 as noted above. In accordance with theillustrated embodiment, the tensioner 28 includes a tensioner housing90, a coupler 30 that extends from the housing 90 and is attached to thedelivery component 26, and a drag member 94 disposed within thetensioner housing 90. The suture 44 extends into the tensioner housing90 through the drag member 94 and such that a frictional force isapplied to the suture 44 by the drag member 94. The tensioner housing 90is coupled the housing 21 a and fixed thereto. The coupler 30 asillustrated is a tubular component that receives the proximal end 27 pof the delivery tube body 80. As illustrated, the delivery tube body 80is fixed to the coupler 30 which indirectly fixes the delivery component26 to the housing 21A.

The suture 44 extends from the proximal end 27 p of the delivery tubebody 80, through the coupler 30, around the pulley 60 and into the dragmember 94 and is spooled within the tensioner housing 90 (not shown).Spooling the suture 44 in tensions housing 90 allows suture 44 todispends from the deployment assembly 14 when the deployment assembly 14is pulled is proximal direction 2 to thereby deploy the sealing device18 (see FIGS. 6F and 6G). The frictional force applied to the suture 44by the drag member 94 can be high enough to maintain the suture 44 intension after the actuator 38 has been actuated and the toggle 40 hasbeen urged against the distal end 27 d of the delivery component 26. Atthe same time the frictional force applied to the suture 44 by the dragmember 94 can be low enough to allow the suture 44 to dispense from thetensioner housing 90 when the deployment assembly 14 is pulled in aproximal direction 4 relative to the toggle 40. In the illustratedembodiment, the drag member 94 is a silicon member that pinches thesuture 44. The tensioner 90 and drag member 94 can be similar thetensioner described in U.S. Patent Application Publication No.2013/0178895. It should be appreciated, however, that the drag member 94can have other configurations as desired.

Turning to FIGS. 6A-6D, the deployment assembly 14 can include one ormore actuators that are configured to transition the release component22 into to releasing position and to cause a tension to be applied tosuture 44 when toggle 40 is released from the release component 22 asdescribed above. As noted above, the actuator 38 can include the matingmember 68 that operatively engages the mating member 64 of the releasecomponent 22 such that motion of the actuator 38 relative to the handlemember 20 causes the release component to translate in the proximaldirection 4 and further applies a tension to the filament.

In accordance with the illustrated embodiment, the actuator 38 can beconfigured as a lever that is rotatably coupled to the handle member 20.The actuator 38 or lever can include a pair of side members 71 a and 71rotatably coupled to each side of the housing 21 a, a first leg 37 athat extends from one of the side members 71 a, a second leg 37 b thatextends from the other side member 71 b, and a transverse member 39 thatconnects the first leg 37 a to the second leg 37 b. The actuator 38 isconfigured to pivot about a pivot axis A_(P) that is perpendicular tothe axis 6. The pivot axis A_(P) may or may not intersect axis 6. Thehousing 21 a defines a curved housing slot 67 that is curved withrespect to the pivot axis A_(P). The curved housing slot 67 has a firstend 69 a (FIG. 6D) and second end (not numbered) spaced apart from thefirst end along the proximal direction 4. The mating member 68 of theactuator 38 can be a pin 68 that is coupled to and extends between theside members 71 and 71 b at a location that is offset from the pivotaxis A_(P). The pin 68 extends through curved housing slot 67 andthrough the elongate slots 64 a and 64 a of the hub 24 of the releasecomponent 22 such that the actuator 38 is operatively coupled to therelease component 22.

In use, as the actuator 38 pivots about the pivot axis A_(P), the pin 68moves from the first end 69 a the curved housing slot 67 toward thesecond end of the curved housing slot 67, and also moves along the slots64 a and 64 b along the vertical direction V. Because the releasecomponent 22 is moveable relative to housing 21 a, as pin 68 moves alongthe curved housing slot 67, the pin 68 advances the hub 24 of therelease component 22 in the proximal direction 4. The result inaccordance with the illustrated embodiment is that rotation of theactuator 38 causes the release component 22 to translate in thelongitudinal direction L. It should be appreciated, however, that theactuator 38 can have other configurations as desired and is not limitedto the disclosed lever.

In operation, the deployment assembly 14 is initially configured toinsert the toggle 40 into the vessel. When the actuator 38 is actuated,the release component 22 moves in the proximal direction 4 relative tothe delivery component 26 into the releasing position (not illustrated)thereby releasing the proximal end 41 p of the toggle 40 from betweenthe release component 22 and the delivery component 26. As the releasecomponent 22 moves in the proximal direction 4, the suture 44 will bepulled in the proximal direction 4 to thereby place the suture 44 intension and urge the toggle 40 against the distal end 27 d of thedelivery component 26. At this point, the toggle 40 is oriented in thesealing position (see FIG. 6E). Accordingly, the release component 22 isconfigured to restrain the toggle 40 of the sealing device 18 duringinsertion of the vascular closure device 12 into the vessel andsubsequently release the toggle 40 so that the toggle 40 can be orientedfor the sealing procedure.

The release component 22 is also in communication the suture 44 via thepulley 60 such that when the actuator 38 is actuated the releasecomponent 22 pulls the suture 44 in the proximal direction to therebyplace the suture 44 in tension. Application of tension along the suture44 urges the toggle 40 against the distal end 27 d of the deliverycomponent 26 and orients the toggle 40 into the sealing position. In theillustrated embodiment, the actuator 38 and release component 22 areconfigured such that continuous movement of the actuator 38 relative tothe housing 21 a will move the release component 22 in the proximaldirection 4, thereby releasing the toggle 40 from the release component22 and subsequently apply tension to the suture 44. It should beappreciated, however, that in some embodiments the suture 44 can betensioned as the toggle 40 is being released. It should further beappreciated that in some embodiments, the deployment assembly 14 caninclude a first actuator to release the toggle 40 and a second actuatorthat tensions the suture 44.

The release component 22 and delivery components 26 are described abovehas having tubular shaped bodies. It should be appreciated that therelease and delivery components can have other configurations. Forinstance, the release component can be elongate rod, or an elongate rodwith a tubular ring coupled to its distal end. The delivery componentcan be configured such that only a portion thereof has a tubular shape.

Embodiments of the present technology will now be described with respectto exemplary large bore procedures that utilize the vascular closuresystem 100 illustrated in FIGS. 7A-7F. In order to perform any of therelated procedures, the user gains percutaneous access to, for example,the femoral artery, causing a puncture site in the artery. To gainpercutaneous access to the artery, the Seldinger technique may be used.For example, a hollow bore needle is inserted into the vessel 200through a procedure sheath PS (referred to as the first access sheath).A guidewire is then advanced through the hollow needle into the femoralartery a sufficient distance to allow removal of the needle without theguidewire pulling out of the vessel. Removing the needle leaves theguidewire in place, with a portion of the guidewire extending into theartery and proximal end PE of the sheath PS extending out patient. Theguidewire, extending from outside the patient into the femoral artery,provides for an entry guide for other medical devices including theaccess sheath 23, introducer 100, and vascular closure device 12.Therefore, once the guidewire is positioned in the vessel of thepatient, catheters, or introducers, of gradually increasing diametersare advanced over the guidewire and through the puncture into the arteryto further open the puncture site. Then, a procedure access sheath set(i.e. an introducer 100 inside a procedure sheath PS) is moved along theguidewire such that a distal end DE of the sheath PS moves into thevessel through the puncture site. And once positioned, the introducercan be removed such that the sheath provides for sizable access to thevessel interior from outside the body. After the relevant procedure iscompleted, the puncture site in the artery created during percutaneousaccess of the artery may be closed. The vascular closure system may beused to seal the puncture site.

In some instances, however, access through the femoral artery asdescribed above is not indicated due to condition of the vessel betweenthe femoral artery and the aorta. In such cases, a trans-caval procedurecan be used to access the aorta. As shown in FIG. 7A, the trans-cavalprocedure includes guiding a guidewire 35 through into through a firstpuncture 202 in a femoral vein 200 and further into and a portion of theinferior vena cava 210. The method include creating a second puncture212 in the portion of the inferior vena cava 210 and creating a thirdpuncture 222 in a femoral artery 220 and a portion of the aorta 220. Thepunctures can formed with a tip of the guidewire 35, such as by burning.Next, the distal end DE of the procedure access sheath PS is guidedalong the guidewire 35 through the second and third punctures. When thesheath PS is in place, a medical device, such as a catheter, is insertedthrough the first access sheath PS. When the procedure is completed, thecatheter is removed from the procedure access sheath PS and theguidewire 35.

Continuing with FIG. 7A, a method includes positioning a tapered distalend 104 of an introducer over a proximal end 36 of a guidewire 35 thatextends through a puncture 202 in a vessel 200, e.g. a vena cava, suchthat the guidewire 35 enters a bore 108 of the introducer. In theexample illustrated, the procedure sheath PS and guidewire 35 extendsfrom the outside the patient into the femoral venal cava.

Next, as shown in FIG. 7B, the method includes advancing the introducer100 along the guidewire 35 in a distal direction 4 so that the tapereddistal end enters the proximal end PE of the first access sheath PS. Theintroducer 100 further advanced out of a distal end DE of the accesssheath PS that is spaced from the proximal end PE of the access sheathPS in the distal direction 4. The introducer 100 is advanced in thedistal direction until a marker 130 disposed toward the tapered distalend is positioned within a predetermined distance of the puncture of thevessel.

As shown in FIGS. 7B and 7C, the method includes removing the accesssheath PS from the punctures 202, 212 and 214 while maintaining aportion of the tapered distal end 104 of the introducer 100 in the aorta220 (or some other vessel as the case may be).

As shown in FIG. 7D, after the removing step, the procedure includes thestep of inserting the access sheath 23 of system 10 (also referred to asthe second access sheath) over the tapered proximal end of theintroducer until a distal or front end 31 of the access sheath 23extends through the puncture of the vessel.

As shown in FIG. 7D, the method includes the step of removing theintroducer 100 from the access sheath 23 and the guidewire 35. Theexchange of sheaths PS and 23 limits blood loss and ensure smoothtransition between the interventional procedure and sealing the puncturesite.

As shown in FIG. 7E, the method includes advancing a vascular closuredevice, for instance the deployment assembly 14, into the access sheath23 to seal the puncture. In one example, the method can also include thesteps of sealing the puncture 222, sealing puncture 212 and sealingpuncture 202. In most cases, the sealing device 18 is deployed asillustrated in FIG. 7F. As deployed, the toggle 40 is adjacent thevessel wall 204, the plug 88 is collapses against the outer surface ofthe wall 204 and opposite the toggle 40. The knot 232 and lock member230 secure the plug 88 in place, compressing the plug 88 and toggle 40together.

It should be appreciated that the introducer 100 can be assembled duringmanufacture or at the surgical site prior to its use as described above.The method can include coupling a distal component 110 of the introducer100 to a proximal component 120 of the introducer, wherein the distalcomponent 110 defines the tapered distal end 104 and the proximalcomponent 120 defines the tapered proximal end 106.

The method described above is related to a trans-caval procedure. Itshould be appreciated that the vascular closure system can be used toseal punctures in a femoral artery. In particular, the vascular closuresystem may be used to see so-call large bore punctures, such as 10 FFrench, 12 French, 14 French or larger sized bore. Such a system istypically used to seal a puncture in vessel within patient's limb.

While the foregoing description and drawings represent the preferredembodiment of the present invention, it will be understood that variousadditions, modifications, combinations and/or substitutions may be madetherein without departing from the spirit and scope of the presentdisclosure as defined in the accompanying claims. In particular, it willbe clear to those skilled in the art that the present disclosure may beembodied in other specific forms, structures, arrangements, proportions,and with other elements, materials, and components, without departingfrom the spirit or essential characteristics thereof. One skilled in theart will appreciate that the present disclosure may be used with manymodifications of structure, arrangement, proportions, materials, andcomponents, which are particularly adapted to specific environments andoperative requirements without departing from the principles of thepresent disclosure. In addition, features described herein may be usedsingularly or in combination with other features. For example, featuresdescribed in connection with one component may be used and/orinterchanged with features described in another component. The presentlydisclosed embodiment is therefore to be considered in all respects asillustrative and not restrictive, the scope of the present disclosurebeing indicated by the appended claims, and not limited to the foregoingdescription. It will be appreciated by those skilled in the art thatvarious modifications and alterations of the present disclosure can bemade without departing from the broad scope of the appended claims. Someof these have been discussed above and others will be apparent to thoseskilled in the art.

We claim:
 1. A system configured to seal a puncture in a vessel,comprising: an introducer configured to be inserted through the puncturealong a guidewire that extends through the puncture into the vessel, theintroducer including an introducer body that is elongate along a centralaxis, a proximal tapered tip, a distal tapered tip that is opposite tothe proximal tapered tip along the central axis, and a bore that extendsfrom the proximal tapered tip to the distal tapered tip along thecentral axis, the bore sized to receive the guidewire therethrough,wherein the distal tapered tip is configured to be inserted into thevessel along the guidewire; an access sheath configured to be insertedover the introducer and into the vessel, the access sheath including afront end, a rear end opposite to the front end, and a lumen thatextends from the front end to the rear end, wherein the proximal taperedtip of the introducer is configured to be inserted through the front endand into the lumen of access sheath such that a movable interference fitis attained between the access sheath and the introducer; and a vascularclosure device including a sealing element configured to seal thepuncture of the vessel, wherein when the introducer has been removedfrom the lumen of the access sheath, the rear end of the access sheathis configured to receive the vascular closure device such that thesealing element extends out of the front end of the access sheath. 2.The system of claim 1, wherein the introducer includes a proximalcomponent that defines the proximal tapered tip, and a distal componentthat defines the distal tapered tip, wherein the proximal and distalcomponents are configured to be coupled together to define theintroducer body.
 3. The system of claim 2, wherein the proximalcomponent defines a proximal portion of the bore and the distalcomponent defines a distal portion of the bore that is aligned with theproximal portion of the bore when the proximal and distal components arecoupled together.
 4. The system of claim 2, wherein the proximalcomponent and the distal component are configured to be coupled togethervia one of a) an interference fit, b) a snap-fit connection, or c) athreaded connection.
 5. The system of claim 2, wherein the proximalcomponent defines a first engagement member opposite to the proximaltapered tip, and the distal component defines a second engagement memberopposite to the distal tapered tip, wherein the first engagement memberis configured to engage the second engagement member so as to couple theproximal and distal components together.
 6. The system of claim 5,wherein one of the first engagement member and the second engagementmember define external threads, and the other of the first engagementmember and the second engagement member define internal threadsconfigured to threadably mate with the external threads.
 7. The systemof claim 5, wherein one of the first engagement member and the secondengagement member defines a ridge, and the other of the first engagementmember and the second engagement member defines a groove that is sizedto receive the ridge.
 8. The system of claim 2, further comprising acoupler having a first end and a second end opposite the first end, thefirst end configured to be coupled to the proximal component and thesecond end configured to be coupled to the distal component, such thatthe proximal component, the coupler, and the distal component define theintroducer.
 9. The system of claim 1, wherein the introducer bodydefines an outer cross-sectional dimension that is perpendicular to thecentral axis, wherein the outer cross-sectional dimension does not varyalong an entirety of the introducer body between the proximal taperedtip and the distal tapered tip.
 10. The system of claim 1, wherein theintroducer body defines an outer surface, and the proximal tapered tiptapers from the outer surface toward the central axis along a proximaldirection away from the distal tapered tip, wherein the proximaldirection is aligned with the central axis.
 11. The system of claim 10,wherein the distal tapered tip tapers from the outer surface toward thecentral axis along a distal direction that is opposite to the proximaldirection.
 12. The system of claim 1, wherein the introducer bodyfurther defines an introducer length that extends from the proximaltapered tip to the distal tapered tip along the central axis, and theaccess sheath defines a sheath length that extends from the front end tothe rear end, wherein the introducer length is at least two times longerthan the sheath length.
 13. The system of claim 1, wherein theintroducer body further defines an introducer length that extends fromthe proximal tapered tip to the distal tapered tip along the centralaxis, wherein the introducer length is between about 120 cm and about130 cm.
 14. The system of claim 13, wherein the introducer length isbetween about 123 cm and about 127 cm.
 15. The system of claim 14,wherein the introducer length is about 125 cm.
 16. The system of claim1, wherein the introducer body further defines an introducer length thatextends from the proximal tapered tip to the distal tapered tip alongthe central axis, wherein the introducer length is between about 20 cmand about 30 cm.
 17. The system of claim 13, wherein the introducerlength is between about 23 cm and about 27 cm.
 18. The system of claim14, wherein the introducer length is about 25 cm.
 19. The system ofclaim 1, wherein the introducer body includes at least one marker. 20.The system of claim 19, wherein a distance from the distal tapered tipto the at least one marker is less than a distance from the at least onemarker to the proximal tapered tip.
 21. The system of claim 19, whereinthe at least one marker is one of a radio opaque band, a radio opaqueink, or a radio opaque paint.
 22. The system of claim 1, wherein therear end of the access sheath includes a hub that is configured to becoupled to a portion of the vascular closure device, wherein the sealingelement extends out from the front end of the access sheath when theportion of the vascular device is coupled to the hub.
 23. An introducerconfigured to be disposed along a guidewire into a puncture of a vessel,the introducer comprising: a proximal introducer component that iselongate along a central axis, the proximal introducer componentdefining a proximal tapered tip, a proximal engagement member oppositeto the proximal tapered tip along the respective central axis, and aproximal bore that extends from the proximal tapered tip to the proximalengagement member; and a distal introducer component that is elongatealong the respective central axis, the distal introducer componentdefining a distal tapered tip, a distal engagement member opposite tothe distal tapered tip along the respective central axis, and a distalbore that extends from the distal tapered tip to the distal engagementmember, wherein the proximal engagement member is configured to engagethe distal engagement member to couple the proximal and distalintroducer components together, such that the proximal bore is alignedwith the distal bore along the respective central axis and the guidewireis receivable through the aligned proximal and distal bores.
 24. Theintroducer of claim 23, wherein one of the proximal engagement memberand the distal engagement member define external threads, and the otherof the proximal engagement member and the distal engagement memberdefine internal threads configured to threadably mate with the externalthreads.
 25. The introducer of claim 23, wherein one of the proximalengagement member and the distal engagement member defines a ridge, andthe other of the proximal engagement member and the distal engagementmember defines a groove that is sized to receive the ridge.
 26. Theintroducer of claim 23, wherein at least one of the proximal introducercomponent and the distal introducer component includes at least onemarker, wherein the at least one marker is one of a radio opaque band, aradio opaque ink, or a radio opaque paint.
 27. The introducer of claim23, wherein the proximal and distal introducer components when coupledtogether defines an introducer length that extends from the proximaltapered tip to the distal tapered tip along the central axis, whereinthe introducer length is between about between about 120 cm and about130 cm.
 28. A method comprising the steps of: positioning a tapereddistal end of an introducer over a proximal end of a guidewire thatextends through a puncture in a vessel such that the guidewire enters abore of the introducer; advancing the introducer along the guidewire ina distal direction so that the tapered distal end enters a proximal endof a first access sheath positioned in the puncture of the vessel and isfurther advanced out of a distal end of the first access sheath that isspaced from the proximal end of the first access sheath in the distaldirection; removing the first access sheath from the puncture whilemaintaining a portion of the introducer tapered distal end of theintroducer in the vessel; after the removing step, inserting a secondaccess sheath over the tapered proximal end of the introducer until adistal end of the second access sheath extends through the puncture ofthe vessel, such that a movable interference fit is attained between thesecond access sheath and the introducer; and advancing a vascularclosure device into the second access sheath to seal the puncture. 29.The method of claim 28, further comprising the steps of removing theintroducer from the second access sheath and the guide wire.
 30. Themethod of claim 29, wherein in the second advancing step includesadvancing the introducer in the distal direction until a marker disposedtoward the tapered distal end is positioned within a predetermineddistance of the puncture of the vessel.
 31. The method of claim 28,further comprising the steps of coupling a distal component of theintroducer to a proximal component of the introducer, wherein the distalcomponent defines the tapered distal end and the proximal componentdefines the tapered proximal end.
 32. The method of claim 28, whereinprior to the positioning step, removing a catheter from the first accesssheath and the guidewire.
 33. The method of claim 32, wherein prior tothe removing step, performing a surgical procedure in the second vessel,where the surgical procedure includes the steps of: a. guiding aguidewire through into through a first puncture in the first vessel,wherein the first vessel includes a femoral vein and a portion of theinferior vena cava; b. creating a second puncture in the portion of theinferior vena cava; c. creating a third puncture in a second vessel,wherein the second vessel includes a femoral artery and a portion of theaorta; d. inserting the distal end of the first access sheath along theguide wire through the second and third punctures along the guide wire;e. inserting the catheter through the first access sheath.
 34. Themethod of claim 33, further comprising the steps of: a. sealing thefirst puncture; b. sealing the second puncture; and c. sealing the thirdpuncture.